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A Study of Nuzefatide Pevedotin (BT5528) for Metastatic Pancreatic Cancer

This study is testing a drug called nuzefatide pevedotin (BT5528) for adults with metastatic pancreatic ductal adenocarcinoma (PDAC), a type of pancreatic cancer that has spread and worsened after one previous treatment. The drug is designed to target a protein called EphA2, which is often found on cancer cells. The main goals are to see how well the drug works against the cancer, what side effects it might have, and how your body handles it. All participants will receive nuzefatide pevedotin, and both you and your doctors will know you are receiving the drug. The study is looking for about 39 participants and is currently unclear on its recruitment status.

Study design
This is a Phase 2, open-label study, meaning everyone receives the study drug and knows what they are getting. It will include approximately 39 participants.
What's involved
Participants will receive nuzefatide pevedotin (BT5528) through an IV (intravenous) infusion every two weeks.
Compensation
Not stated in the trial record.
Follow-up
The study will measure how well the drug works for up to approximately 3 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07450859

A Study of Nuzefatide Pevedotin (BT5528) in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)

Recruiting
PHASE2Ages 18+InterventionalTreatment
BicycleTx Limited
~39 participants
Updated 2026-09-17 on ClinicalTrials.gov
What's tested:nuzefatide pevedotin (BT5528)

At a glance

Recruiting sites
8 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective Response Rate (ORR)
Measured over Up to approximately 3 years

Conditions

Pancreatic Ductal Adenocarcinoma (PDAC)

Explore related trials

Pancreatic Ductal AdenocarcinomaEPHA2 Gene

NCT07450859

Where you'd take part

This study runs at 8 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Mayo Clinic Arizona

    Phoenix, Arizonastudy coordinator listed

    Recruiting

  • Mayo Clinic Florida

    Jacksonville, Floridastudy coordinator listed

    Recruiting

  • Mayo Clinic Rochester

    Rochester, Minnesotastudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Cancer Center - Main Campus

    New York, New Yorkstudy coordinator listed

    Recruiting

  • Siteman Cancer Center (Washington University School of Medicine)

    St Louis, Missouristudy coordinator listed

    Recruiting

  • Thomas Jefferson University, Sidney Kimmel Comprensive Cancer Center, Clinical Trials Office

    Philadelphia, Pennsylvaniastudy coordinator listed

    Recruiting

  • Samsung Medical Center

    Seoul, South Koreano site contact published

    Recruiting

  • Seoul National University Hospital

    Seoul, South Koreano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

BicycleTx Limited
[email protected]
6179458155
Email the study team

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Eligibility criteria

Inclusion

At least 18 years of age at the time of signature of the informed consent form (or at least 19 years where locally defined as minimum age of consent).
Measurable disease as defined by RECIST v1.1.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Life expectancy of at least 12 weeks.
Histologically confirmed metastatic pancreatic ductal adenocarcinoma (PDAC).
Participants must have failed whose disease has progressed on or after only 1 prior line of therapy or on or after second line therapy with a KRAS inhibitor, with evidence of radiographic progression. Neoadjuvant or adjuvant systemic therapy may count as the first line if the participant progressed less than 6 months from the end of systemic therapy. Prior treatment with KRAS inhibitors in the first-line setting is permitted if there was no intervening treatment prior to enrollment.
Participants must have sufficient tumor tissue (fresh or archived) available for analysis of EphA2 tumor expression and other biomarkers.
Adequate organ function (hematologic, renal, and hepatic).
Negative pregnancy test for participants of childbearing potential (POCBP)
Must be willing and able to comply with the protocol and study procedures and agree to participate in the study by providing written informed consent.

Exclusion

Chemotherapy or radiotherapy within 14 days prior to the first dose of study treatment
Experimental treatments within 28 days or 5 half-lives, whichever is longer, of first dose of nuzefatide study treatment
Prior treatment with taxane therapy (e.g., paclitaxel) for pancreatic cancer or prior treatment with any MMAE-containing agent
Known microsatellite instability-high (MSI-H) status and are eligible for immune checkpoint inhibitor therapy
Prior toxicities must have resolved to Grade 1 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v6.0
Untreated central nervous system (CNS) metastases

What this trial measures

  • Objective Response Rate (ORR)Up to approximately 3 years

    Percentage of participants who achieve a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the Investigator